Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

NCT ID: NCT04131530

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-31

Study Completion Date

2019-12-31

Brief Summary

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Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

Detailed Description

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Conditions

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Ulcerative Colitis Artificial Intelligence Confocal Laser Endomicroscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colon mucosa observed by pCLE

pCLE is used to evaluate the inflammation activity in different parts of the colon mucosa

The diagnosis of Artificial Intelligence and endoscopist

Intervention Type DIAGNOSTIC_TEST

When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Interventions

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The diagnosis of Artificial Intelligence and endoscopist

When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* aged between 18 and 80; diagnosed as UC

Exclusion Criteria

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of QiLu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li

Role: CONTACT

053182169385

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

053182169385

Other Identifiers

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2019SDU-QILU-10

Identifier Type: -

Identifier Source: org_study_id

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